PHADEBACT HAEMOPHILUS TEST
FDA 510(k) clearance K802423 · decided 1980-11-12
Clearance details
- K-number
- K802423
- Device name
- PHADEBACT HAEMOPHILUS TEST
- Applicant
- Pharmacia, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1980-10-03
- Decision date
- 1980-11-12
- Days to decision
- 40 days
- Clearance type
- Traditional
- Product code
- GRO
- Device class
- 2
- Regulation number
- 866.3300
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| LEGIONELLA CULTURE CONFIRMATIN KIT (K851271) | Gen-Probe, Inc. | 1985-07-08 |
| LEGIONELLA DIFFERENTIATION DISK (K834067) | Remel Co. | 1984-01-03 |
| BACTOGEN-H. INFLUENZAE TYPE B (K800493) | Armkel, LLC | 1980-04-04 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| MODELS 011 & 011B IRIDOCAPSULAR IOLS (P810042) | Pharmacia, Inc. | 1982-12-15 |